FDA.reportPublic FDA data

Double Spike Infiltration Tubing

Primary DI
30816989020080
Brand
Double Spike Infiltration Tubing
Company
HK SURGICAL INC.
Model
ITD-20
Catalog number
ITD-20
Device description
INFILTRATION TUBING SET
Published
2020-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGZAccessories, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38169890200082PreviousGS10
30816989020080PrimaryGS10
10816989020086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3816989020008238169890200082
3081698902008030816989020080
1081698902008610816989020086

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
949-369-0101hkinfo@hksurgical.com

Regulatory Flags#

DUNS number
106885259
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816989021468HK Klein Infiltration Pump+KIP-II+KIP-II+2025-09-29
00816989020874"HK Tumescent Infiltration Cannula, (15cm) 6""-12 gauge, Single Use, Box of 10"SU-IC12x15SU-IC12x152020-11-20
00816989021437HK Klein TDD PumpKTDDKTDD2024-08-29
00816989021130HK Mercedes Cannula 3mm X 15cm Luer LockHKMER315HKMER3152023-12-21
00816989021147HK Mercedes Cannula 2mm X 15cm Luer LockHKMER215HKMER2152023-12-21
00816989021154HK Mercedes Cannula 3mm X 25cm Luer LockHKMER325HKMER3252023-12-21
00816989021161"HK Mercedes Cannula 3mm X 30cm (12"") Luer Lock"HKMER330HKMER3302023-12-21
00816989021178HK Mercedes Cannula 4mm X 25cm Luer LockHKMER425HKMER4252023-12-21
00816989021185"HK Mercedes Cannula 4mm X 30cm (12"") Luer Lock"HKMER430HKMER4302023-12-21
00816989021192HK HK-2015-MER+215LL (HK-2015 Mercedes Plus Cannula 2mm x 15cm Luer Lock)HKMER+215HKMER+2152023-12-21
00816989021208HK Mercedes Plus Cannula 3mm X 25cm Luer LockHKMER+325HKMER+3252023-12-21
00816989021215HK Mercedes Plus Cannula 4mm X 25cm Luer LockHKMER+425HKMER+4252023-12-21
00816989021222HK Tri-port Cannula 3mm x 25cm Luer LockHKTRI325HKTRI3252023-12-21
00816989021239HK Tri-port plus Cannula 2mm x 15cm Luer LockHKTRI+215HKTRI+2152023-12-21
00816989021246HK Tri-port plus Cannula 3mm x 25cm Luer LockHKTRI+325HKTRI+3252023-12-21
00816989021253HK Tri-port plus Cannula 4mm x 25cm Luer LockHKTRI+425HKTRI+4252023-12-21
00816989021260HK Spatula Single Hole Cannula 12ga x 15cm Luer LockHKSPA1215HKSPA12152023-12-21
00816989021277HK Spatula Single Hole Cannula 14ga x 15cm Luer LockHKSPA1415HKSPA14152023-12-21
00816989021284"HK Spatula Single Hole Cannula 3mm X 15cm (6"") Luer Lock"HKSPA315HKSPA3152023-12-21
00816989021291HK TOL Toledo Cannula 2mm x 15cm Luer LockHKTOL215HKTOL2152023-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329837365BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
00840329837372BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
00840329837389BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
10198459435201MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
10704411017882AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
10192253053609DevonCardinal Health 200, LLCKGZ2025-03-25
10192253042023DevonCardinal Health 200, LLCKGZ2025-03-07
10192253042030DevonCardinal Health 200, LLCKGZ2025-03-07
00840306835087Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835094Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835100Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835131Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
30382904275656BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
30382904275618BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275625BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275632BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275649BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275601BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-16
00815634021761FibrijetMicromedics, Inc.KGZ2024-06-18
00628725047638Safety Drain line adapterCanadian Hospital Specialties LimitedKGZ2024-06-17
10193489068245NAMICMEDLINE INDUSTRIES, INC.KGZ2023-12-21
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10193489068115MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068122MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140187MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140194MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
M710WW12K0Wire Watch™BIOTEX, INC.KGZ2023-07-31
10850005416002MedDrainARMM INC.KGZ2023-06-08
10850005416019MedDrainARMM INC.KGZ2023-06-08
10850005416033MedDrainARMM INC.KGZ2023-06-08